K052601

Substantially Equivalent

STOCKERT HEATER-COOLER SYSTEM 3T

Applicant: Sorin Group Deutschland GmbH
Product code: DWC
Advisory panel: Cardiovascular
Date received: 2005-09-21
Decision date: 2006-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Adverse events under product code DWC

product code DWC

Death: 124
Injury: 233
Malfunction: 3,727
Total: 4,084

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.